BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCAR 2, 250D

    MDR report key: 9730018 · Received February 19, 2020

    Report

    Report Number
    1036863-2020-00003
    Event Type
    Malfunction
    Date Received
    February 19, 2020
    Date of Event
    January 6, 2020
    Report Date
    January 23, 2020
    Manufacturer
    SUNTECH MEDICAL, INC.
    Product Code
    DXN
    PMA / PMN Number
    K151500
    Removal / Correction Number
    84531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SECRETARY OF THE CENTER PUT BATTERIES THAT WERE INCLUDED IN THE ORIGINAL PACKAGING IN THE DEVICE AND START THE DEVICE. THE DEVICE WAS THEN GIVEN TO THE PATIENT, TURNED ON AND A MEASUREMENT WAS PERFORMED TO VERIFY PROPER FUNCTIONING OF THE DEVICE. A FEW MOMENT AFTER, IT WAS REALIZED THAT THE DEVICE WAS HOT AND BATTERIES WERE REMOVED IMMEDIATELY. BATTERIES WERE HOT. AS NO DAMAGE WAS OBSERVED ON THE DEVICE, THE SECRETARY PUT OTHER BATTERIES (DIFFERENT FROM ORIGINAL PACKAGING) AND PROPER FUNCTIONING OF THE DEVICE WAS OBSERVED. THERE IS NO INDICATION ABOUT BATTERIES POSITION WHEN THE EVENT OCCURRED, THE SECRETARY DO NOT KNOW IF BATTERIES WERE APPROPRIATELY INSERTED OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190903 OSCAR 2, 250D SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN SUNTECH MEDICAL, INC. 250D

    Patients

    Seq Age Sex Outcome Treatment
    1